Section 493.1100 - Condition: Facility administrationEach laboratory that performs nonwaived testing must meet the applicable requirements under §§ 493.1101 through 493.1105 , unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7 ).
(a)Reporting of SARS-CoV-2 test results. During the Public Health Emergency, as defined in § 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. 68 FR 3703 , Jan. 24, 2003, as amended at 85 FR 54873 , Sept. 2, 2020